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Vaccine Safety in the United States: Overview and Considerations for COVID-19 Vaccines [November 4, 2020]
From the Document: "Widespread immunization efforts have been linked to increased life expectancy and reduced illness. U.S. vaccination programs, headed by the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), have helped eradicate smallpox and nearly eradicate polio globally, and eliminate several infectious diseases domestically. With the Coronavirus Disease 2019 (COVID-19) pandemic now causing major health and economic impacts across the world, efforts are underway to make safe and effective vaccines available quickly to help curb spread of the virus."
Library of Congress. Congressional Research Service
Sekar, Kavya; Dabrowska, Agata
2020-11-04
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FDA's Role in the Medical Product Supply Chain and Considerations During COVID-19 [September 1, 2020]
From the Background: "The Coronavirus Disease 2019 (COVID-19) pandemic has affected the medical product supply chain globally and domestically. Although certain concerns about the U.S. medical product supply chain predate the emergence of COVID-19, the ongoing pandemic has made addressing those concerns and understanding the supply chain a more urgent priority. Of particular concern for some are the United States' reliance on foreign sources of medical products and the federal government's ability to oversee the supply chain and mitigate future disruptions."
Library of Congress. Congressional Research Service
Green, Victoria R.; Dabrowska, Agata; Costin, Kate M.
2020-09-01
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U.S. Blood Supply and the COVID-19 Response: In Brief [Updated August 26, 2020]
From the Introduction: "The response to the COVID-19 [coronavirus disease 2019] pandemic has posed significant challenges for the U.S. blood supply. Mitigation strategies to prevent the spread of COVID-19, such as closures of schools and workplaces, have led to blood drive cancellations. In addition to blood drive cancellations, individual state stay-at-home orders and general fear of contracting the COVID-19 virus might dissuade individuals from scheduling appointments to donate blood. [...] This report provides a brief background of the regulatory framework for the U.S. blood supply, explains the federal response to the current crisis, and discusses potential treatment of COVID-19 using blood-derived products."
Library of Congress. Congressional Research Service
Sussman, Jared S.; Dabrowska, Agata
2020-08-26
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Development and Regulation of Medical Countermeasures for COVID-19 (Vaccines, Diagnostics, and Treatments): Frequently Asked Questions [June 25, 2020]
From the Summary: "In recent months, the Coronavirus Disease 2019 (COVID-19) pandemic has spread globally, with the United States now reporting the highest number of cases of any country in the world. Currently, there are few treatment options available to lessen the health impact of the disease and no vaccines or other prophylactic treatments to curb the spread of the virus. [...] This report answers frequently asked questions about current efforts related to research and development of medical countermeasures, their regulation, and related policy issues. Although several efforts are underway, medical product research, development, and approval is a difficult and high-risk endeavor that takes years in typical circumstances. In response to COVID-19, this process has been expedited, including through several federal programs and mechanisms covered in this report. However, expedited medical product development can carry certain risks, such as a more limited safety profile for new products upon approval."
Library of Congress. Congressional Research Service
Dabrowska, Agata; Gottron, Frank; Sarata, Amanda K. . . .
2020-06-25
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U.S. Blood Supply and the COVID-19 Response: In Brief [May 28, 2020]
From the Summary: "The nation's blood supply is largely managed by a network of independent blood centers and the American Red Cross, with some oversight from the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). These private organizations collect blood product donations (e.g., whole blood, plasma, and platelets) from individual volunteers through scheduled appointments, walk-in appointments, and blood drives. Independent blood centers and the American Red Cross each collect nearly half of blood products nationwide, with the remainder collected in hospital settings. The response to the Coronavirus Disease 2019 (COVID-19) pandemic has posed significant challenges for maintenance of the U.S. blood supply. Mitigation strategies to prevent the spread of COVID-19, such as closures of schools and workplaces, have led to blood drive cancellations at the places where such events are often held. In addition to blood drive cancellations, individual state stay-at-home orders and general fear of contracting the COVID-19 virus might dissuade individuals from scheduling appointments to donate blood."
Library of Congress. Congressional Research Service
Sussman, Jared S.; Dabrowska, Agata
2020-05-28
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Treatment of COVID-19: Hydroxychloroquine and Chloroquine [Updated May 27, 2020]
From the Document: "To date, the U.S. Food and Drug Administration (FDA) has not approved any therapeutics--drugs or biologics--for the treatment of COVID-19 [coronavirus disease 2019]. However, FDA has authorized the emergency use of three drugs, including two drugs that have been approved by FDA for other uses: hydroxychloroquine sulfate ('hydroxychloroquine') and chloroquine phosphate ('chloroquine'). The agency authorized the emergency use of both drugs on March 28, 2020. [...] Some stakeholders--including several former FDA officials--have expressed concern regarding FDA's EUA [emergency use authorization], stating that current data regarding the safety and effectiveness of these drugs for treatment of COVID-19 are largely anecdotal and that expanding access may jeopardize research into the drug. On April 24, 2020, FDA issued a drug safety communication warning against the use of these drugs for treatment of COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. Further, the National Institutes of Health (NIH) treatment guidelines on use of antivirals for COVID-19 state that '[t]here are insufficient clinical data to recommend either for or against using chloroquine or hydroxychloroquine for the treatment of COVID-19' and recommend against using high-dose chloroquine for the treatment of COVID-19."
Library of Congress. Congressional Research Service
Dabrowska, Agata; Green, Victoria R.
2020-05-27
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Treatment of COVID-19: Hydroxychloroquine and Chloroquine [April 20, 2020]
From the Document: "To date, the U.S. Food and Drug Administration (FDA) has not approved any therapeutics--drugs or biologics--for the treatment of COVID-19 [coronavirus disease 2019]. However, FDA has authorized the emergency use of two drugs: hydroxychloroquine sulfate ('hydroxychloroquine') and chloroquine phosphate ('chloroquine'). The agency has determined that based on the totality of scientific evidence, 'it is reasonable to believe that [chloroquine] and [hydroxychloroquine] may be effective in treating COVID-19,' and that when used in accord with the conditions of the emergency use authorization (EUA), the known and potential benefits outweigh the known and potential risks of these drugs. Some stakeholders--including several former FDA officials--have expressed concern regarding FDA's EUA, stating that current data regarding the safety and effectiveness of these drugs for treatment of COVID-19 are largely anecdotal and that expanding access may jeopardize research into the drug. When asked whether there is evidence that hydroxychloroquine may be effective as a prophylaxis against COVID-19, Dr. Anthony Fauci--Director of the National Institute of Allergy and Infectious Diseases (NIAID)--has said 'the answer is no' and that with respect to hydroxychloroquine as a treatment '[w]e still need to do the definitive studies to determine whether any intervention, not just this one, is truly safe and effective.'"
Library of Congress. Congressional Research Service
Dabrowska, Agata; Green, Victoria R.
2020-04-20
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Food and Drug Administration (FDA) Budget: Fact Sheet [Updated April 2, 2020]
From the Summary: "The Food and Drug Administration (FDA) regulates the safety of foods (including dietary supplements), cosmetics, and radiation-emitting products; the safety and effectiveness of drugs, biologics (e.g., vaccines), and medical devices; and public health aspects of tobacco products. [...] FDA's 'total program level,' the amount that FDA can spend, is composed of discretionary appropriations from two different sources: annual appropriations (i.e., discretionary budget authority, or BA) and user fees paid by the regulated industry (e.g., drug manufacturers). In FDA's annual appropriation, Congress sets both the total amount of appropriated funds and the amount of user fees that the agency is authorized to collect and obligate for that fiscal year. [...] The Administration's FY2021 budget request for a 'total program level' of $6.044 billion would be an increase of $123 million (+2%) over the FY2020-enacted amount ($5.921 billion). This report will be updated with information on FDA funding for FY2021 once legislative action on appropriations for the new fiscal year is completed."
Library of Congress. Congressional Research Service
Dabrowska, Agata; Green, Victoria R.
2020-04-02
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Personal Protective Equipment and Ventilators for COVID-19: FDA Regulation and Related Activities [April 2, 2020]
From the Document: "The Coronavirus Disease 2019 (COVID-19) pandemic has affected the medical product supply chain both globally and domestically. Perhaps most salient has been the impact of COVID-19 on the availability of personal protective equipment (PPE), such as gowns and masks, for health care personnel, and respiratory devices, including ventilators, for patients. In the United States, respiratory devices and PPE used in the health care setting meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act (FFDCA) and are regulated by the U.S. Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS). This In Focus provides an overview of how these devices are regulated and summarizes the FDA response to mitigate reported PPE and ventilator shortages related to COVID-19."
Library of Congress. Congressional Research Service
Dabrowska, Agata; Green, Victoria R.
2020-04-02
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Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123): First Coronavirus Supplemental [March 25, 2020]
From the Introduction: "By late February and early March 2020, the global outbreak of Coronavirus Disease 2019 (COVID-19), a viral respiratory illness caused by a novel coronavirus, had entered a new phase, with community spread occurring in many countries and several U.S. states. Concerns grew over the potential for the disease to spread widely, leading to increased hospitalizations and deaths. On March 6, 2020, Congress and the President enacted the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123), to provide emergency supplemental appropriations to prevent, prepare for, and respond to the coronavirus outbreak. This report provides an overview of appropriations in Division A and relevant policies and requirements pursuant to the supplemental. Funding in Division A is designated as being provided as an emergency requirement. For the purposes of the supplemental, the term 'coronavirus' refers to SARS-CoV-2, the virus that causes COVID-2019, or another coronavirus with pandemic potential."
Library of Congress. Congressional Research Service
Sekar, Kavya; Dabrowska, Agata; Lindsay, Bruce R. . . .
2020-03-25
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Overview of U.S. Domestic Response to Coronavirus Disease 2019 (COVID-19) [Updated March 2, 2020]
From the Background: "This report discusses selected actions taken by the U.S. federal government to quell the introduction and spread of COVID-19 [coronavirus disease 2019] in the United States. The President, the HHS [Health and Human Services] Secretary, and other federal officials have taken several specific actions to address this threat. While some of these actions are based in generally applicable authorities, others may be contingent upon the Secretary or another federal official making a determination or declaration, specific to that action, regarding the existence of a public health emergency or threat. Key actions and their legal basis are discussed in this report."
Library of Congress. Congressional Research Service
Lister, Sarah A.; Sekar, Kavya; Dabrowska, Agata . . .
2020-03-02
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FDA Regulation of Cannabidiol (CBD) Consumer Products [Updated February 10, 2020]
From the Document: "Cannabidiol (CBD) is promoted as treatment for a range of conditions, including anxiety, pain, inflammation, and post-traumatic stress disorder--despite limited scientific evidence to substantiate or disprove many of these claims. CBD is derived from the 'Cannabis sativa' plant (commonly referred to as cannabis), which includes both marijuana and hemp. CBD and tetrahydrocannabinol (THC) are thought to be the most abundant cannabinoids in cannabis. CBD is considered to be nonpsychoactive and may be derived from either hemp or marijuana. THC--a psychoactive compound--is found at high levels in marijuana and low levels in hemp."
Library of Congress. Congressional Research Service
Dabrowska, Agata; Johnson, Renée
2020-02-10
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Overview of U.S. Domestic Response to the 2019 Novel Coronavirus (2019-nCoV) [February 10, 2020]
From the Background: "This report discusses selected actions taken by the federal government to quell the introduction and spread of 2019-nCoV [2019 Novel Coronavirus] in the United States. The HHS [U.S. Department of Health and Human Services] Secretary has taken several specific actions to address the 2019-nCoV threat. While some of these actions are based in generally applicable authorities of the Secretary, other authorities may be contingent upon the Secretary or another federal official making a determination or declaration, specific to that authority, regarding the existence of a public health emergency or threat. Each of the actions taken by the Secretary, its statutory basis, and any distinct declarations and determinations supporting the action is presented in this report."
Library of Congress. Congressional Research Service
Lister, Sarah A.; Sekar, Kavya; Dabrowska, Agata . . .
2020-02-10
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FDA Regulation of Cannabidiol (CBD) Consumer Products: Overview and Considerations for Congress [January 21, 2020]
From the Document: "Cannabidiol (CBD), a compound in the 'Cannabis sativa' plant, has been promoted as a treatment for a range of conditions, including epileptic seizures, post-traumatic stress disorder, anxiety, inflammation, and sleeplessness. However, limited scientific evidence is available to substantiate or disprove the efficacy of CBD in treating these conditions. In the United States, CBD is marketed in food and beverages, dietary supplements, cosmetics, and tobacco products such as electronic nicotine delivery systems (ENDS)--products that are primarily regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.). CBD is also the active ingredient in Epidiolex, an FDA-approved pharmaceutical drug."
Library of Congress. Congressional Research Service
Dabrowska, Agata; Green, Victoria R.; Johnson, Renée . . .
2020-01-21
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FDA Regulation of Cannabidiol (CBD) Products [June 12, 2019]
"Cannabidiol (CBD) is promoted as treatment for a range of conditions, including epileptic seizures, post-traumatic stress disorder, anxiety, and inflammation--despite limited scientific evidence to substantiate many of these claims. In the United States, CBD is marketed in food and beverages, dietary supplements, and cosmetics--products that are regulated by the Food and Drug Administration (FDA). CBD is also the active ingredient in an FDA-approved pharmaceutical drug, Epidiolex®. CBD is a plant-derived substance from 'Cannabis sativa', the species of plant that includes both hemp and marijuana, but from different plant varieties or cultivars. CBD is the primary nonpsychoactive compound in cannabis, whereas tetrahydrocannabinol (THC) is cannabis's primary psychoactive compound."
Library of Congress. Congressional Research Service
Dabrowska, Agata
2019-06-12
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Biologics and Biosimilars: Background and Key Issues [Updated June 6, 2019]
From the Summary: "A biological product, or biologic, is a preparation, such as a drug or a vaccine, that is made from living organisms. Compared with conventional chemical drugs, biologics are relatively large and complex molecules. They may be composed of proteins (and/or their constituent amino acids), carbohydrates (such as sugars), nucleic acids (such as DNA), or combinations of these substances. Biologics may also be cells or tissues used in transplantation. A biosimilar, sometimes referred to as a follow-on biologic, is a therapeutic drug that is highly similar but not structurally identical, to a brand-name biologic (i.e., the reference product). [...] The FDA [Food and Drug Administration] regulates both biologics and chemical drugs. Before a biologic or biosimilar may be marketed in the United States, it must be licensed (i.e., approved) by FDA. [...] The high costs of pharmaceuticals in general--and biologics in particular--has led to an increased interest in understanding the federal government's role in the development of costly new therapeutics. In the case of many biosimilars approved by FDA, the associated brand-name biologic was originally discovered by scientists at public-sector research institutions. These brand-name biologics--Remicade, Enbrel, Humira, Avastin--are among the top-selling drugs in the United States and worldwide."
Library of Congress. Congressional Research Service
Dabrowska, Agata
2019-06-06
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SUPPORT for Patients and Communities Act (P.L. 115-271): Food and Drug Administration and Controlled Substance Provisions [November 15, 2018]
"The SUPPORT [Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment] Act is a sweeping measure designed to address widespread overprescribing and abuse of opioids in the United States. The act includes provisions involving law enforcement, public health, and healthcare financing and coverage. Broadly, the legislation imposes tighter oversight of opioid production and distribution; imposes additional reporting and safeguards to address fraud; and limits coverage of prescription opioids, while expanding coverage of and access to opioid addiction treatment services. The bill also authorizes a number of programs that seek to expand consumer education on opioid use and train additional providers to treat individuals with opioid use disorders."
Library of Congress. Congressional Research Service
Dabrowska, Agata; Green, Victoria R.; Sacco, Lisa N. . . .
2018-11-15
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Emergency Use Authorization and FDA's Related Authorities [August 13, 2018]
"Under most circumstances, drugs, medical devices, and biologics may only be introduced into interstate commerce if they have been approved, cleared, or licensed by the Food and Drug Administration (FDA). Under certain circumstances, however, FDA may permit a medical product to be provided to patients outside the standard regulatory framework. One of these circumstances is if the Secretary of Health and Human Services (HHS) declares, pursuant to §564 of the Federal Food, Drug, and Cosmetic Act (FFDCA), that an emergency or threat exists due to a chemical, biological, radiologic, or nuclear (CBRN) agent, in which case the HHS Secretary may temporarily authorize the emergency use of an unapproved product or the unapproved use of an approved product. P.L. 115-92, signed into law on December 12, 2017, amended this authority to allow for emergency uses of medical products for threats in addition to CBRN agents, to include agents that may cause or are associated with an imminently lifethreatening and specific risk to the United States military."
Library of Congress. Congressional Research Service
Dabrowska, Agata
2018-08-13
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How FDA Approves Drugs and Regulates Their Safety and Effectiveness [May 8, 2018]
"The Food and Drug Administration (FDA), a regulatory agency within the Department of Health and Human Services, regulates the safety and effectiveness of drugs sold in the United States. FDA divides that responsibility into two phases. In the preapproval (premarket) phase, FDA reviews manufacturers' applications to market drugs in the United States; a drug may not be sold unless it has FDA approval. Once a drug is on the market, FDA continues its oversight of drug safety and effectiveness. That postapproval (postmarket) phase lasts as long as the drug is on the market. Beginning with the Food and Drugs Act of 1906, Congress and the President have incrementally refined and expanded FDA's responsibilities regarding drug approval and regulation."
Library of Congress. Congressional Research Service
Dabrowska, Agata; Thaul, Susan
2018-05-08
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Nutrition Labeling of Restaurant Menu and Vending Machine Items [February 5, 2018]
"This report discusses the role of nutrition labeling in obesity management and prevention; the research on the effectiveness of restaurant menu calorie labeling; FDA's [Food and Drug Administration] authority to regulate nutrition labeling; and the FDA's final rules on restaurant menu and vending machine labeling. The report also identifies issues for Congress and flags stakeholders' concerns regarding FDA's final menu labeling rule."
Library of Congress. Congressional Research Service
Dabrowska, Agata
2018-02-05
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Comparison of the Bills to Extend State Children's Health Insurance Program (CHIP) Funding [January 17, 2018]
"The State Children's Health Insurance Program (CHIP) is a means-tested program that provides health coverage to targeted low-income children and pregnant women in families that have annual income above Medicaid eligibility levels but have no health insurance. CHIP is jointly financed by the federal government and the states, and the states are responsible for administering CHIP. In statute, FY2017 was the last year a federal CHIP appropriation was provided. Federal CHIP funding was not extended before the beginning of FY2018. As a result, states do not currently have full-year FY2018 CHIP allotments and states are funding their CHIP programs with unspent federal CHIP funds from prior years. The continuing resolutions enacted on December 8, 2017, and December 22, 2017, both include provisions that provide short-term funding for CHIP. The continuing resolution enacted on December 8, 2017, includes a special rule for redistribution funds, and the continuing resolution enacted on December 22, 2017, includes short-term appropriations and an extension of the special rule for redistribution funds. This short-term funding is not sufficient to fund CHIP through the end of FY2018.There are a couple of bills that would extend federal funding for CHIP for five years. On October 4, 2017, both the Senate Finance Committee and the House Energy and Commerce Committee had markups on different bills that would extend CHIP federal funding through FY2022, among other provisions."
Library of Congress. Congressional Research Service
Mitchell, Alison; Baumrucker, Evelyne P.; Dabrowska, Agata . . .
2018-01-17
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Drug Compounding: FDA Authority and Possible Issues for Congress [January 5, 2018]
"Drug compounding is a process by which a pharmacist or physician combines, mixes, or alters various drug ingredients to create a drug to meet the unique needs of an individual patient for whom an approved drug may not be appropriate (e.g., due to an allergy to a dye in the product). [...] In working to address the issues raised by stakeholders and maintain public health protections, policymakers may consider issues such as patient access, drug quality, and the necessity of compounded drugs. For patients with a legitimate medical need, preserving timely access to compounded medications has been identified as a concern by supporters of office-use compounding. However, in the context of patient safety, drug quality is also a consideration. Compounded drugs are not evaluated by the Food and Drug Administration (FDA) prior to marketing, and pharmacies that compound pursuant to The Federal Food, Drug, and Cosmetic Act (FFDCA) Section 503A are not required to register with FDA or report adverse events to the agency. For these reasons, among others, FDA maintains that compounded drugs pose a higher risk than FDA-approved drugs. A third consideration is necessity, specifically whether pharmacies need to compound for office-use. If a hospital, clinic, or health care practitioner wants to keep compounded drugs in stock for office-use, these entities can generally obtain non-patient-specific compounded products from outsourcing facilities that are registered with FDA and subject to more stringent regulatory requirements."
Library of Congress. Congressional Research Service
Dabrowska, Agata
2018-01-05
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Comparison of the Bills to Extend State Children's Health Insurance Program (CHIP) Funding [November 3, 2017]
"The State Children's Health Insurance Program (CHIP) is a means-tested program that provides health coverage to targeted low-income children and pregnant women in families that have annual income above Medicaid eligibility levels but have no health insurance. CHIP is jointly financed by the federal government and the states, and the states are responsible for administering CHIP. In statute, FY2017 is the last year a federal CHIP appropriation is provided. Federal CHIP funding was not extended before the beginning of FY2018. As a result, states do not currently have FY2018 CHIP allotments, and states are funding their CHIP programs with unspent federal CHIP funds from prior years. Some states are expected to exhaust this funding within the first quarter of FY2018."
Library of Congress. Congressional Research Service
Mitchell, Alison; Baumrucker, Evelyne P.; Dabrowska, Agata . . .
2017-11-03
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Comparison of the Bills to Extend State Children's Health Insurance Program (CHIP) Funding [October 23, 2017]
"The State Children's Health Insurance Program (CHIP) is a means-tested program that provides health coverage to targeted low-income children and pregnant women in families that have annual income above Medicaid eligibility levels but have no health insurance. CHIP is jointly financed by the federal government and the states, and the states are responsible for administering CHIP. In statute, FY2017 is the last year a federal CHIP appropriation is provided. Federal CHIP funding was not extended before the beginning of FY2018. As a result, states do not currently have FY2018 CHIP allotments, and states are funding their CHIP programs with unspent federal CHIP funds from prior years. Some states are expected to exhaust this funding within the first quarter of FY2018. On October 4, 2017, both the Senate Finance Committee and the House Energy and Commerce Committee had markups on different bills that would extend CHIP federal funding through FY2022, among other provisions."
Library of Congress. Congressional Research Service
Mitchell, Alison; Baumrucker, Evelyne P.; Dabrowska, Agata . . .
2017-10-23
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Public Health Service Agencies: Overview and Funding (FY2016-FY2018) [August 16, 2017]
"The Department of Health and Human Services (HHS) has designated 8 of its 11 operating divisions (agencies) as components of the U.S. Public Health Service (PHS). The PHS agencies are (1) the Agency for Healthcare Research and Quality (AHRQ), (2) the Agency for Toxic Substances and Disease Registry (ATSDR), (3) the Centers for Disease Control and Prevention (CDC), (4) the Food and Drug Administration (FDA), (5) the Health Resources and Services Administration (HRSA), (6) the Indian Health Service (IHS), (7) the National Institutes of Health (NIH), and (8) the Substance Abuse and Mental Health Services Administration (SAMHSA). The PHS agencies all provide and support essential public health services; however, their specific missions vary. With the exception of FDA, the agencies have limited regulatory responsibilities. Two of them--NIH and AHRQ--are primarily research agencies. NIH conducts and supports basic, clinical, and translational medical research. AHRQ conducts and supports research on the quality and effectiveness of health care services and systems."
Library of Congress. Congressional Research Service
Redhead, C. Stephen; Dabrowska, Agata; Bagalman, Erin . . .
2017-08-16
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Public Health Service Agencies: Overview and Funding (FY2015-FY2017) [May 19, 2016]
From the Congressional Research Service (CRS), this report describes the source of funding within eight agencies. "Within the Department of Health and Human Services (HHS), eight agencies are designated components of the U.S. Public Health Service (PHS). The PHS agencies are funded primarily with annual discretionary appropriations. They also receive significant amounts of funding from other sources including mandatory funds from the Affordable Care Act (ACA), user fees, and third-party reimbursements (collections)." The eight agencies are as follows: the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Agency for Toxic Substances and Disease Registry (ATSDR), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and the Substance Abuse and Mental Health Services Administration (SAMHSA). [...] "This report is a new edition of an earlier product, which remains available: CRS Report R43304, Public Health Service Agencies: Overview and Funding (FY2010-FY2016) [Fiscal Year]. It will be updated with information on PHS agency funding for FY2017 once legislative action on appropriations for the new fiscal year is completed."
Library of Congress. Congressional Research Service
Redhead, C. Stephen; Dabrowska, Agata; Bagalman, Erin . . .
2016-05-19
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Dietary Guidelines for Americans: Frequently Asked Questions [February 2, 2016]
From the Summary: "The Dietary Guidelines for Americans (DGA) is a policy document that provides federally developed, nutrition-based recommendations for Americans two years of age and older. The guidelines are statutorily mandated under the 1990 National Nutrition Monitoring and Related Research Act (P.L. 101-445), which requires the Departments of Health and Human Services (HHS) and Agriculture (USDA) to jointly publish the DGA policy document at least once every five years. The DGA forms the basis for all federal nutrition policies, including the National School Lunch Program and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). The guidelines also (1) influence food and nutrition labeling; (2) guide local, state, and national health promotion and disease prevention initiatives; and (3) inform various organizations and industries (e.g., products developed and marketed by the food and beverage industry)."
Library of Congress. Congressional Research Service
Dabrowska, Agata
2016-02-02
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Public Health Service Agencies: Overview and Funding (FY2010-FY2016) [October 13, 2015]
"Within the Department of Health and Human Services (HHS), eight agencies are designated components of the U.S. Public Health Service (PHS). The PHS agencies are funded primarily with annual discretionary appropriations. They also receive significant amounts of funding from other sources including mandatory funds from the Affordable Care Act (ACA), user fees, and third-party reimbursements (collections)." These departments consist of the following: Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Agency for Toxic Substances and Disease Registry (ATSDR), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Substance Abuse and Mental Health Services Administration (SAMHSA).
Library of Congress. Congressional Research Service
Redhead, C. Stephen; Dabrowska, Agata
2015-10-13
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Public Health Service Agencies: Overview and Funding (FY2010-FY2016) [October 2, 2015]
"The Department of Health and Human Services (HHS) has designated eight of its 11 operating divisions (agencies) as components of the U.S. Public Health Service (PHS). The PHS agencies are: (1) the Agency for Healthcare Research and Quality (AHRQ), (2) the Agency for Toxic Substances and Disease Registry (ATSDR), (3) the Centers for Disease Control and Prevention (CDC), (4) the Food and Drug Administration (FDA), (5) the Health Resources and Services Administration (HRSA), (6) the Indian Health Service (IHS), (7) the National Institutes of Health (NIH), and (8) the Substance Abuse and Mental Health Services Administration (SAMHSA). […] The PHS agencies are funded primarily with annual discretionary appropriations. They also receive significant amounts of funding from other sources including mandatory funds from the Affordable Care Act (ACA), user fees, and third-party reimbursements (collections)."
Library of Congress. Congressional Research Service
Redhead, C. Stephen; Dabrowska, Agata
2015-10-02
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FDA Finalizes New Rules for Calorie Labeling in Restaurants [December 4, 2014]
"In 2010, President Obama signed the Affordable Care Act (ACA) into law, with a provision mandating nutrition labeling in retail food establishments nationwide. The following year, FDA proposed two rules establishing calorie labeling requirements for food items sold in restaurants and vending machines, both of which were recently finalized (published in the Federal Register on December 1, 2014). The labeling rules are to take effect in one year (December 1, 2015) for restaurants and in two years (December 1, 2016) for vending machines. High rates of obesity and chronic disease have prompted various state and local nutrition labeling initiatives. The 1990 Nutrition Labeling and Education Act (P.L. 101-535) authorized FDA to require nutrition labeling of most foods and dietary supplements but exempted restaurants from this requirement. Yet, consumption data indicates that Americans consume more than one-third of their calories outside the home, and frequent eating out is associated with increased caloric intake. Some studies have shown that posting nutrition information on menus and menu boards in restaurants may help consumers lower their overall calorie intake, prompting public health stakeholders to advocate for federal nutrition labeling standards. Entities covered by the new regulation include restaurants and similar retail food establishments (SRFEs) with 20 or more locations, doing business under the same name and offering the same menu items for sale. The rule also applies to certain foods sold at supermarkets and convenience stores, as well as entertainment venues such as bowling alleys and movie theaters. FDA issued a second rule requiring calorie labeling of food items sold in vending machines, covering those operators who own 20 or more machines nationwide."
Library of Congress. Congressional Research Service
Dabrowska, Agata
2014-12-04
